Provape Enterprise, Inc. – FDA Warning Letter, Sep 22, 2020

On July 31, 2020, the FDA issued a Warning Letter to Artak Stepanyan regarding the sale of Electronic Nicotine Delivery System (ENDS) products on provape.com. The FDA determined that the "Acacia Q-Watch Pod Kit" ENDS product is a "new tobacco product" under section 910(a) of the FD&C Act because it was not commercially marketed in the U.S. as of February 15, 2007.

The product is deemed adulterated under section 902(6)(A) of the FD&C Act for lacking required premarket authorization (marketing authorization order under section 910(c)(1)(A)(i) or substantial equivalence exemption). It is also misbranded under section 903(a)(6) for not providing required notice or information under section 905(j).

The FDA expressed particular concern that the "Acacia Q-Watch Pod Kit" resembles smartwatches, potentially appealing to children and allowing concealment of a tobacco product. This design raises concerns about encouraging unlawful sales to minors and increasing youth ENDS use.

The letter mandates prompt correction of all violations and similar issues. A written response is required within 15 working days, detailing corrective actions, including discontinuation of violative sales/advertising, and a plan for maintaining compliance. Failure to comply may result in regulatory action, including detention and refusal